Efficacy of Diet and Hypnotic Suggestions or Telemedicine in Obesity Management

NCT03811197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-05-27

No results posted yet for this study

Summary

The aim of the study is the assessment of the effectiveness of medical nutrition therapy (MNT) among obese patients, including a well-balanced low-calories diet, an individual dietary counseling conducted by dietitians and supported by telemedicine (T) or hypnotic suggestions (HS).

The study will cover a group of 90 adult patients, both sexes, with obesity (BMI ≥30 kg/m\^2) undergoing MNT a dietetic treatment. Three arms are planned in the study scheme, according to the scheme: Group 1 - individual MNT (30 people); Group 2 -individual MNT and T (30 people); Group 3 - individual MNT and HS (30 people).

The authors hope that the results of the study will allow to develop a new model of the most effective management of obesity, resulting in weight reduction and maintaining this effect over time. The results obtained during the study will also allow to assess the impact of the therapy applied on lifestyle changes, dietary habits and the knowledge about the disease among obese patients.

Conditions

Interventions

BEHAVIORAL

Dietary counseling via face to face meeting

All subjects received individual MNT and individual dietary recommendations based on DASH (Dietary Approaches to Stop Hypertension) diet plan for 6 months (Part A). Dietary counseling is provided by a trained dietitian. Months 9 and 12 - follow up (Part B).

BEHAVIORAL

Telemedicine

All subjects received an additional dietary counseling for 6 months (via internet, messenger or telephone) two weeks after each standard visit will be added to the counseling (Part A). Standard and additional dietary counseling (T) are provided by a trained dietitian. Months 9 and 12 - follow up (Part B).

BEHAVIORAL

Hypnotic Suggestions

All subjects received individual hypnotic suggestion (HS) for 6 months as a supplementary method for dietary counseling. HS will be adapted to the "small steps" method used in the management of obesity. During the visit, HS will be recorded and the individual will listen to it every day (Part A). HS will be provided by a physician, qualified in the field of hypnotherapy. Months 9 and 12 - follow up (Part B).

Sponsors & Collaborators

  • Warsaw University of Life Sciences

    lead OTHER

Principal Investigators

  • Danuta Gajewska, PhD · Department of Dietetics, Warsaw University of Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2019-06-30
Completion
2019-12-10

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811197 on ClinicalTrials.gov